Healthcare - Trade Policy Effective from Mid-June 2018

1. New Regulations on Sampling Drugs to Determine Drug Quality

Circular 11/2018/TT-BYT on drug quality and drug materials issued by the Ministry of Health on May 4, 2018, annuls Circular 04/2010/TT-BYT guiding drug sampling to determine quality.

Drug sampling to determine drug quality shall be carried out according to the new regulations. To be specific:

- For drugs specified at Points a, b Clause 4 Article 103 of the Law on Pharmacy; biologicals derived from human blood and plasma; drugs imported under Article 70 of Decree 54/2017/ND-CP: Sampling shall be conducted by the manufacturing or importing establishment;- For drugs produced by foreign drug manufacturing establishments listed in the list of establishments with drugs violating quality standards: The importing establishment shall request the quality inspection or state drug testing authority to carry out sampling.

View details of Circular 11/2018/TT-BYT which takes effect from June 20, 2018, while rescinding Circular 09/2010/TT-BYT on quality management guidelines for drugs.

1. Traditional Medicine Must Be Quality-Checked Quarterly

This is stipulated in Circular 13/2018/TT-BYT on the quality of medicinal materials and traditional medicine, effective from June 30, 2018. Accordingly:

- Quarterly, medical treatment establishments must send the latest batch of traditional medicine to the state drug testing facility or business providing drug, and drug material testing services certified with GCN for quality inspection.- Additionally, the head of the medical treatment establishment is also responsible for organizing periodic inspections at least once every three months and sudden checks on the quality of medicinal materials and traditional medicine within the establishment.

1. Expanded Authority to Sign BOT, BT Project Contracts from June 19, 2018

On May 4, 2018, the Government of Vietnam passed Decree 63/2018/ND-CP on investment in the form of public-private partnership (PPP). This expands the authority to sign project contracts in cases of authorization. To be specific:

- Ministries and sectors may authorize organizations under their ministries and central authorities; Provincial People's Committees may authorize specialized agencies or District People's Committees to sign and implement project contracts for group B and group C;- Ministries, sectors, and Provincial People's Committees may authorize public service providers that self-assure recurrent expenditures and investment expenditures under their ministries, central, and local authorities to sign and implement project contracts for group B and group C, except for cases applying service contracts according to specialized law (new point).

A project contract is a contract signed to invest in the form of PPP, including types of contracts such as BOT, BT, BOO, BTL, etc.

View details of Decree 63/2018/ND-CP which takes effect from June 19, 2018.

1. Permit Auction Sales for Export of Smuggled Cigarettes

Decision 20/2018/QD-TTg signed by the Prime Minister of Vietnam on April 26, 2018, permits the pilot auction for export of smuggled foreign cigarettes that have been confiscated and meet quality standards.

The auction and export of smuggled cigarettes must comply with the principles:

- Auctions must be conducted according to the provisions of the asset auction law;- Export must be carried out through seaports, waterways, and international airports; it is not allowed to export through land border gates and not to export to countries sharing the land border. If transiting through countries sharing the land border, it must comply with the signed goods transit agreement with those countries;- Export procedures for smuggled cigarettes after successful auction must comply with customs law.

Decision 20 takes effect from June 15, 2018, until June 15, 2020, and temporarily suspends Decision 2371/QD-TTg.

1. Circular 06/2018/TT-BCT guiding detailed measures on trade defense, effective from June 15, 2018.

2. Circular 40/2018/TT-BTC guiding the first-time share sale and management, use of revenue from the equitization of SOEs and single-member LLCs with 100% state-owned charter capital transformed into joint-stock companies, effective from June 18, 2018.

3. Circular 41/2018/TT-BTC guiding financial handling and determining enterprise value when converting SOEs and single-member LLCs with 100% state-owned charter capital into joint-stock companies, effective from June 18, 2018.

4. Circular 09/2018/TT-NHNN stipulating the operational network of credit institutions as cooperatives, effective from June 15, 2018.

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